Commercial Insight: Psoriasis - Intellectual property drives growth

Published by: Datamonitor

Published: Jul. 30, 2009 - 204 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Immunology & Inflammation therapy analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Strategic scoping and focus

Datamonitor insight into the disease market

Related reports

Upcoming related reports

CHAPTER 2 MARKET DEFINITION

Market definition for this report

Biologic therapies

Systemic immunomodulators

Topical corticosteroids

Topical vitamin derivatives

Other

Indication split methodology

Diagnosis value based on retail data only

Country coverage

CHAPTER 3 MARKET OVERVIEW

Seven major markets

Current and future market overview

Biologic and topical vitamin derivative launches spurred psoriasis market growth in 2005-08

Seven major psoriasis market will grow from $2.5 billion in 2008 to $3.5 billion in 2018

Volume analysis shows topical therapies create the cornerstone of treatment

US

Current and future market assessment

US sales jumped between 2005 and 2007, but leveled off by 2007-08

US will continue to be the largest of the seven major markets for psoriasis

Opportunities and threats

Opportunities

Threats

Japan

Current and future market assessment

Japanese psoriasis market growth has been slowed by government price cuts

Biologics and vitamin derivatives will drive psoriasis sales in Japan in 2018

Opportunities and threats

Opportunities

Threats

Five major European markets (5EU)

Current and future market assessment

Opportunities and threats

Opportunities

Threats

European trends

Germany, Italy: topical vitamin derivative license expiries loom

UK: NICE guidance slows uptake of biologics for psoriasis

Rest of the world snapshot

Current market assessment

CHAPTER 4 BRAND DYNAMICS

Overview of competitive landscape

Patient acquisition process

Introduction

Patient care path

Points of influence in the patient care path

Initial therapy recommendation is a key point of influence in psoriasis

Topical treatment efficacy depends heavily on patient compliance

Specialists are more likely to initiate systemic therapy for psoriasis

Drivers of brand choice

Disease modification and long-term efficacy drive prescribing

Efficacy and safety are important to all classes

Perceived safety motivates topical vitamin derivative usage

Speed of action governs the prescribing decision for steroids

US pricing and reimbursement status for leading brands

Trends in marketing strategies

Marketing strategy for leading brands

Sponsorship/disease awareness campaigns

Direct-to-consumer advertising

Overview of biologics in psoriasis

The anti-TNF class dominates biological therapy for psoriasis

More data are required to elucidate biologics' long-term safety in psoriasis

Enbrel (etanercept; Amgen, Pfizer/Wyeth, Takeda)

Drug profile

Product positioning

Enbrel leads the market, but cost-driven prescribing may constrain its efficacy

Prescribers perceive Enbrel as a safer option in biological psoriasis therapy

First pediatric psoriasis indication stands to enhance Enbrel's position

In 2005, Enbrel overstepped its labeling in DTC advertising

Breaking news regarding continuous treatment and an autoinjector in Europe

SWOT analysis

Brand forecast to 2018

Humira (adalimumab; Abbott, Eisai)

Drug profile

Product positioning

Humira's efficacy in psoriasis has helped it gain a foothold quickly

Humira appears set to challenge Enbrel's lead in psoriasis

Humira's market share expands with additional country and pediatric approvals

In 2008, a Humira psoriasis journal advertisement hit a wrong note with the FDA

SWOT analysis

Brand forecast to 2018

Remicade (infliximab; Centocor Ortho Biotech, Merck/Schering-Plough and Mitsubishi Tanabe)

Drug profile

Product positioning

Remicade relies on a long history of use in diverse indications

Remicade defends its position at second/third-line

SWOT analysis

Brand forecast to 2018

Raptiva (efalizumab; Genentech, Merck Serono)

Drug profile

The aftermath of Raptiva's withdrawal

Raptiva was condemned on safety grounds

Humira is set to sweep share from Raptiva by virtue of its efficacy and dosing

Stelara (ustekinumab; Centocor Ortho Biotech, Janssen-Cilag)

Drug profile

Product positioning

Compared to Enbrel, Stelara shines in terms of efficacy

Dosing frequency distinguishes Stelara from marketed biologics

SWOT analysis

Brand forecast to 2018

Dovonex (calcipotriol; Leo Pharma, Warner Chilcott, Intendis Torii and Teikoku Medix)

Drug profile

Product positioning

Leo Pharma's response to generic competition has sparked controversy

Licensing agreements complicate Dovonex's market presence in Europe

SWOT analysis

Brand forecast to 2018

Dovobet (calcipotriol/betamethasone; Leo Pharma, Warner Chilcott, Intendis)

Drug profile

Product positioning

Dovobet is a reformulation with lifecycle management implications

SWOT analysis

Brand forecast to 2018

Silkis/Vectical (calcitriol; Galderma)

Drug profile

Product positioning

Silkis/Vectical marketing pushes brand as an attachment to your regimen in the US

Silkis US formulation patent will not defend the brand for long

SWOT analysis

Brand forecast to 2018

Additional brands

Olux/Olux-E (clobetasol; Stiefel/GlaxoSmithKline)

Olux brand proposition: patient preference for the VersaFoam vehicle

Olux/Olux-E Complete: competitive strategy in a combination pack

Brand forecast to 2018

Clobex (clobetasol propionate; Galderma)

The Clobex brand value proposition is based on innovation

Combining clobetasol and calcitriol in a novel formulation could drive success

Brand forecast to 2018

Soriatane/Neotigason (acitretin; Roche, Actavis, Stiefel/GlaxoSmithKline)

Patents expired but generics not launched, side effects continue to be limiting

Brand Forecasts to 2018

CHAPTER 5 KEY DEVELOPERS

Strategic overview

Recent strategic partnerships and deals

Pfizer and Wyeth

GlaxoSmithKline and Stiefel

Merck and Schering-Plough

Company strategies in psoriasis

Big Pharma-backed biologics create a competitive atmosphere, but psoriasis is not the top earner

Abbott

Amgen and Wyeth

Johnson & Johnson and Schering-Plough

Topical treatments employ a number of strategies to varying success

Leo Pharma's Dovobet shows profitability of fixed dose combinations

Ointment remains the most used formulation, but foams command a higher price

Prodrugs and molecular variations offer limited innovation

CHAPTER 6 CASE STUDIES

Potential impact of biosimilars in the US

Base case: biosimilar impact from 2014

Scenario A: price cuts to innovative biologics but no biosimilars in the next 10 years

Scenario B: 20% price cut and moratorium on price increases from 2014 with biosimilars launch in 2018

Scenario C: biosimilars launch in 2018, without interim action by US payers

BIBLIOGRAPHY

Journal papers

Others

Conference papers

Websites

Other sources

Datamonitor reports

APPENDIX A

Data definitions, limitations and assumptions

Standard units

Lining out of branded products in the forecast versus 'all others'

Diagnosis values for topical products

Assumptions regarding biosimilars

Derivation of sales forecasts and pricing trends

Forecast methodology

APPENDIX B

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the Disease analysis team

Disclaimer

List of Tables

Table 1: Dermatologist breakdown by region for IMS Prescribing Insights data, 2008

Table 2: Sales and growth of drug classes and brands for psoriasis in the seven major markets, 2008-2018

Table 3: Key events impacting the psoriasis market, 2009-2018

Table 4: Psoriasis volume and volume growth for the major drug classes for psoriasis in the seven major markets, 2008-2018

Table 5: Sales forecasts for psoriasis in the seven major markets ($m), 2008-2018

Table 6: Sales and growth of drug classes and brands for psoriasis in the US, 2008-2018

Table 7: Sales forecasts for psoriasis in the US ($m), 2008-2018

Table 8: Summary of opportunities and threats in the psoriasis market in the US, 2009

Table 9: Sales and growth of drug classes and brands for psoriasis in Japan, 2008-2018

Table 10: Sales forecasts for psoriasis in Japan ($m), 2008-2018

Table 11: Summary of opportunities and threats in the psoriasis market in Japan, 2009

Table 12: Sales and growth of drug classes and brands for psoriasis in the five major EU markets, 2008-2018

Table 13: Sales forecasts for psoriasis in the five major EU markets ($m), 2008-2018

Table 14: Summary of opportunities and threats for psoriasis in the five major European markets, 2009

Table 15: Comparison of leading branded drug sales ($m) for psoriasis in the seven major markets and the rest of the world (ROW), 2008

Table 16: Leading branded drug sales for psoriasis in the seven major markets, by class ($m), 2008-2018

Table 17: Dermatologists surveyed regarding psoriasis, 2008

Table 18: Comparison of PASI 50, -75 and -90 scores among the biologic brands

Table 19: Comparative importance of factors affecting dermatologists' prescribing decisions for topical vitamin derivatives by country, points out of 100, 2008

Table 20: Representative formulary tier status in the US for leading brands in psoriasis, 2009

Table 21: Marketing strategies employed by the companies behind the top two biologics for psoriasis, 2009

Table 22: Tuberculosis post-marketing data for TNF inhibitors (rheumatoid arthritis), 2008

Table 23: Enbrel - drug profile, 2009

Table 24: Comparative efficacy of Enbrel (etanercept) and Raptiva (efalizumab) in psoriasis, 2004

Table 25: Comparative cost per QALY of Enbrel (etanercept) and Raptiva (efalizumab) in psoriasis in the UK, 2004

Table 26: Humira (adalimumab) - drug profile, 2009

Table 27: Selected recent Humira (adalimumab) trials in psoriasis, 2009

Table 28: Remicade - drug profile, 2009

Table 29: Selected recent Remicade (infliximab) trials in psoriasis, 2009

Table 30: Raptiva (efalizumab) - drug profile, 2009

Table 31: Stelara (ustekinumab) - drug profile, 2009

Table 32: Projected pricing for Stelara (ustekinumab) based on relative pricing of Humira compared to Germany, 2009 ($/SU)

Table 33: Dovonex (calcipotriol) - drug profile, 2008

Table 34: Dovobet (calcipotriol/betamethasone) - drug profile, 2009

Table 35: Silkis/Vectical (calcitriol) - drug profile, 2009

Table 36: Olux (clobetasol) - drug profile, 2009

Table 37: Olux-E/Olux-E Complete (clobetasol) - drug profile, 2009

Table 38: Clobex (clobetasol propionate) - drug profile, 2009

Table 39: Soriatane/Neotigason (acitretin) - drug profile, 2009

Table 40: Leading companies in the seven major market for psoriasis-specific sales, 2008-2018

Table 41: Comparative price ($ per patient year) of topical treatments by formulation, 2008

Table 42: Potential scenarios for US biosimilar entry

Table 43: Base case forecast impact of biosimilars by country

List of Figures

Figure 1: Psoriasis sales by drug class in the seven major markets ($m), 2005-08

Figure 2: Key events impacting the psoriasis market, 2005-09

Figure 3: Psoriasis-specific value ($m) and volume (SU/dose/year) by class, 2008 and 2018

Figure 4: Psoriasis sales by drug class in the US ($m), 2005-08

Figure 5: Psoriasis sales by drug class in Japan ($m), 2005-08

Figure 6: Price per standard unit ($/SU) for Remicade (infliximab) in Japan, Q1 2007-Q2 2008

Figure 7: Psoriasis sales by drug class in the five major EU markets ($m), 2005-08

Figure 8: Effect of expiration of distribution agreement between Schering (now Intendis) and Leo Pharma on the Psorcutan Beta and Dovobet brands of calcipotriol/betamethasone topical combinations for psoriasis in Germany ($m), 2005-2018f

Figure 9: Effect of expiration of distribution agreement between Schering (now Intendis) and Leo Pharma on the Token (Psorcutan Beta) and Dovobet brands of calcipotriol/betamethasone topical combinations for psoriasis in Italy ($m), 2005-2018f

Figure 10: Psoriasis sales ($m) and growth of biologics in the five major EU markets, 2005-08

Figure 11: Global psoriasis sales breakdown, 2008

Figure 12: Annual estimated psoriasis sales outside the seven major markets, 2005-08

Figure 13: Psoriasis patient path

Figure 14: Mean non-pharmacological and pharmacological treatment rates in psoriasis across the seven major markets, 2008

Figure 15: Drivers of brand choice for psoriasis, 2009

Figure 16: Comparative importance of factors affecting dermatologist prescribing decisions by class across the seven major markets, 2008

Figure 17: Screenshot of Humira of patient assistance program targeting all patients

Figure 18: Screenshot of Enbrel patient assistance program targeting all patients

Figure 19: Screenshot of LeAnn Rimes' story, www.stophiding.org

Figure 20: Screenshot of advertising information, www.psoriasis.org

Figure 21: Biologics launch dates, by indication, across the seven major markets, 1998-2009

Figure 22: Enbrel (etanercept) SWOT analysis, 2009

Figure 23: Enbrel (etanercept) psoriasis sales by country across the seven major markets ($m), 2008-2018

Figure 24: Abbott Humira advertisement in American Academy of Dermatology Post-Meeting News, 2008

Figure 25: Humira (adalimumab): SWOT analysis, 2009

Figure 26: Humira (adalimumab) psoriasis sales by country across the seven major markets ($m), 2008-2018

Figure 27: Remicade SWOT analysis, 2009

Figure 28: Remicade (infliximab) psoriasis sales by country across the seven major markets ($m), 2008-2018

Figure 29: Datamonitor estimated biologic market share, 2008 and 2010

Figure 30: Apotheke.de screenshot showing the price of Stelara

Figure 31: Stelara (ustekinumab) SWOT analysis, 2009

Figure 32: Stelara (ustekinumab) psoriasis sales by country, across the seven major markets ($m), 2008-2018

Figure 33: Dovonex (calcipotriol) SWOT analysis

Figure 34: Dovonex (calcipotriol) psoriasis sales by country across the seven major markets ($m), 2008-2018

Figure 35: Dovobet (calcipotriol/betamethasone) SWOT analysis, 2009

Figure 36: Dovobet (calcipotriol/betamethasone) psoriasis sales by country in the US and 5EU ($m), 2008-2018

Figure 37: Vectical brand website with Choose Vectical rationale, Galderma US, 2009

Figure 38: Vectical trial comparisons, Vectical brand website, Galderma US, 2009

Figure 39: Splash page, Vectical brand website, Galderma US, 2009

Figure 40: Vectical brand website outlining regime Galderma USA, 2009

Figure 41: Silkis/Vectical (calcitriol) SWOT analysis, 2009

Figure 42: Silkis/Vectical (calcitriol) psoriasis sales in the US and 5EU ($m), 2008-2018

Figure 43: Olux brand website, Stiefel Laboratories, 2009

Figure 44: Olux/Olux-E (clobetasol) psoriasis sales by country, in the US, UK and Italy ($m), 2008-2018

Figure 45: Clobex (clobetasol) psoriasis sales by country in the US and 5EU ($m), 2008-2018

Figure 46: Soriatane/Neotigason (acitretin) psoriasis sales by country in the US and 5EU ($m), 2008-2018

Figure 47: Pfizer and Wyeth's company-reported global prescription sales and Datamonitor forecasts split by therapy area ($m), 2002-2014

Figure 48: Merck and Schering-Plough's company-reported global prescription sales and Datamonitor forecasts split by therapy area ($m),, 2002-2014

Figure 49: Psoriasis-specific sales for key biologic brands, in the seven major markets ($m), 2008-2018

Figure 50: Proportion of total brand sales attributed to psoriasis for key biologic brands in the seven major markets ($m), 2008 and 2018

Figure 51: Importance of Humira within Abbott portfolio, company-reported global sales and Datamonitor forecast, ($ billion), 2008-2014

Figure 52: Importance of Enbrel within the Wyeth and Amgen portfolios, company-reported global sales and Datamonitor forecast, ($ billion), 2008-2014

Figure 53: Importance of Remicade within the Schering-Plough and Johnson & Johnson portfolios, company-reported global sales and Datamonitor forecast, ($ billion), 2009-2014

Figure 54: Psoriasis-specific sales split by delivery method across the seven major markets ($m), 2004-08

Figure 55: Successful uptake of Dovobet showing some switch from Dovonex in the seven major markets ($m), 2005-08

Figure 56: Topical vitamin derivatives and corticosteroids by formulation in the seven major markets ($m), 2005-2018

Figure 57: Vitamin D analog structures

Figure 58: US psoriasis-specific biologic sales ($m), 2008-2018

Figure 59: Remicade price cut and recovery in Japan ($/SU), 2008

Figure 60: Scenario A: US psoriasis-specific sales ($m), 2008-2018

Figure 61: Scenario B: US psoriasis-specific sales ($m), 2008-2018

Figure 62: Scenario C: US psoriasis-specific sales ($m), 2008-2018

Abstract

• Analysis of the current and future market dynamics in psoriasis across the US, France, Germany, Italy, Spain the UK and Japan
• Assessment of biologic, vitamin derivative, topical corticosteroid and immunomodulator classes
• Psoriasis-specific forecast data for indication scrutiny, but total brand data also included to put sales in context for brand and company
• Scenario forecasts for go/no-go on biosimilar legislation and the impact of possible additional cost containment measures

• Assess the impact of the economic downturn on psoriasis, which is vulnerable to cost-saving behavior compared to other autoimmune disorders
• Assess the impact of new brands on the market and consider the value to volume ratio for the key classes
• See how psoriasis contributes to total brand sales and company portfolios

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